The FDA’s proposal to enhance regulatory oversight of modifications made to already-cleared devices ruffled some feathers among the medtech industry, which warned that more rigid oversight could triple the agency’s work without conferring much benefit to public safety.
510(k) reforms
FDA analysis: 510(k) is here to stay, says medtech attorney
The FDA’s less-stringent 510(k) medical device review pathway is no stranger to criticism, but it has at least 1 fan – Hyman, Phelps & McNamara attorney Jeffrey Shapiro.
Shapiro defended the fast-track review pathway, which doesn’t usually require that medical device companies submit to U.S. clinical trials in order to demonstrate safety and efficacy, and he expects that the 510(k) system will "be around for a long time."
Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser
Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.
The patient safety advocate and vocal critic of the FDA announced at this year’s American College of Cardiology conference that he’s working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.
Researchers call for more stringent FDA oversight of medtech | MassDevice.com On Call
MASSDEVICE ON CALL — A commentary co-authored by the California and Australian researchers called for the FDA to close the 510(k) "loophole" that allows medical devices considered a potentially "high risk" to patients to enter the U.S. market without undergoing clinical trials.
FDA’s medtech review Plan of Action cuts review times, lowers application backlog
The FDA’s 36-point "Plan of Action" for improving its medical device review program produced success in turning around a process that had been worsening for nearly a decade, according to the federal watchdog agency.
The FDA reported that it "successfully increased the predictability, consistency, transparency, efficiency, and timeliness of premarket review," thanks to a 2-year initiative that included efforts to better manage agency resources, remove unnecessary regulatory burdens and bring in outside experts to streamline medical device review.
The IRS gears up to tackle Obamacare | MassDevice.com On Call
MASSDEVICE ON CALL — The U.S. Internal Revenue Service should have its hands full in dealing with implementation of the new taxes and rules contained in the Affordable Care Act.
The federal agency must handle more than 40 changes to the tax code as well as make sure appropriate recipients get new tax credits and individuals and businesses pay penalties for any non-compliance.
FDA proposes new 510(k) pre-review to cut out incomplete applications
The FDA issued new recommendations for improving the 510(k) medical device review process by installing a pre-review assessment that would check applications and reject submissions dubbed incomplete.
The proposal is one of the FDA’s attempts to make good on the promises it made to the medical device industry in the latest iteration of the Medical Device User Fee & Modernization Act. The federal watchdog agency vowed to streamline its application review process in exchange for a doubling of fees that companies pay when submitting for review.
Four medical implants that escaped FDA scrutiny
by Lena Groeger, ProPublica
Exposed FDA docs reveal misgivings about EU’s device review system
In an apparent effort to push back against medical device industry lobbying, the FDA crafted an internal report outlining agency successes in keeping "malfunctioning or needlessly invasive high-risk medical devices" off the U.S. market, despite their approval in the European Union.
The gesture may represent a response to FDA critics, who have long called the the agency’s medical device pathways inconsistent, unpredictable and lacking in transparency. The same critics often point to the EU’s less-stringent review system as a model for the U.S.
GOP Sens. Burr and Coburn team up for PATIENTS’ FDA Act
Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced a new bill today aimed at reducing the medical device industry’s regulatory burden.
The duo’s "Patients’ Act" (Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA) would "ensure that the FDA is held accountable for its performance goals and is fulfilling its public health mission on behalf of patients in a predictable and timely manner, including decisions on life-saving drugs and devices," according to a press release.
MassDevice.com +3 | The top 3 med-tech stories for April 19, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.